Kit Rop Blepharo S/Depresseur 2en1
EUDAMEDFDA UDIClass I (EU MDR)
by Moria S.A.
Identity
- Trade Name
- KIT ROP BLEPHARO S/DEPRESSEUR 2EN1 EUDAMEDONE FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- ROP Exam Kit-D EUDAMED
- Model / Reference
- 17210 EUDAMED17263X10 EUDAMEDROP KIT XS SPECULUM/2IN1 DEPRESSOR FDA UDI
Identifiers
- Catalog Number
- 17263X10 FDA UDI
- Primary DI / UDI-DI
- 03700483625734 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836ScleralsF8 EUDAMED
- FDA Product Code
- HNX FDA UDI
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Kit Rop Blepharo S/Depresseur 2en1 by Moria S.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37004836ScleralsF8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Moria S.A.
- EUDAMED SRN
- FR-MF-000000336
Sources (2)
- EUDAMED df12bb4a-fcdc-4bc5-a6c6-ac5fd0c8e0ac 61 fields · synced Jun 18, 2026
- FDA UDI 8706376e-3d3e-48ab-8f00-64536e00f8e4 33 fields · synced May 30, 2026